Status:
COMPLETED
Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis
Lead Sponsor:
Aesculap AG
Conditions:
Peripheral Vascular Diseases
Hemostasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this trial is to demonstrate that the bleeding time of suture holes after construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than with Surgicel®
Detailed Description
Hemostasis in peripheral vascular surgery is made more difficult by the need for direct arterial and arterial graft suturing as well as by systemic anticoagulation to prevent thrombosis during periods...
Eligibility Criteria
Inclusion
- Patients with an indication for a peripheral vascular reconstruction due to peripheral vascular disease (PVD) including femoro-femoral, femoro-popliteal and femoro-crural reconstructions or the need of a crossover including femoro-femoral or ilaco-femoro reconstruction.
- suture hole bleeding of peripheral arterial bypass anastomosis using PTFE graft prosthesis
- Written informed consent
Exclusion
- Emergency surgery
- Patients with coagulopathy or uremia
- Reoperation within one month at the same location
- Pregnant and Breastfeeding Women
- Known or suspected allergies or hypersensitivity to any of the used devices (e.g. to material of bovine origin)
- Severe comorbidity (ASA ≥ 4)
- Life expectancy less than 12 months
- Current immunosuppressive therapy (more than 40 mg of corticoid per day or ezathioprin)
- Chemotherapy within last 4 weeks
- Radiotherapy on the treated region within the last 2 months
- Severe psychiatric or neurologic diseases
- Lack of compliance
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00837954
Start Date
February 1 2009
End Date
April 1 2010
Last Update
May 28 2015
Active Locations (1)
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1
Klinikum Hanau GmbH, Gefaesschirurgie
Hanau, Hesse, Germany, 63450